MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN PROGRIP MESH PRODUCT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Foreign Body Reaction (1868); Pain (1994); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

Title: long term results of open complex abdominal wall hernia repair with self-gripping mesh: a retrospective cohort study source: http://dx.Doi.Org/10.1016/j.Ijsu.2017.07.029 1743-9191/© 2017 ijs publishing group ltd.Published by elsevier ltd.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to a literature source of study performed between june 2012 and june 2015, that evaluated the safety and feasibility of the self-gripping polyester mesh in retromuscular position for the treatment of complex abdominal wall hernia repair.A total of 46 patients were treated in netherlands were included.Among them, 40 patients (87%) were diagnosed with incisional hernia.Seven patients (18%) had incisional hernia combined with another hernia.Four patients (8.7%) had an umbilical hernia, one patient (2.2%) had an epigastric hernia and one patient (2.2%) had rectus diastasis.All hernias were considered as complex.Considering the short-term follow-up (three months): three patients had adverse events during primary hospital admission.One patient had an extended hospital stay of 17 days because of postoperative ileus, which was treated conservatively; one suffered from postoperative angina pectoris, one patient had postoperative pneumonia, and was successfully treated with antibiotics.Ten patients (21.7%) were diagnosed with a postoperative seroma.One was treated with an ultrasound-guided puncture and nine patients were treated conservatively.Five patients showed an adverse event during outpatient follow-up.One patient showed a hematoma which was treated conservatively.Four patients were readmitted to the hospital for various reasons.Two were readmitted for 11 days and 5 days respectively because of administering intravenous antibiotics for the treatment of wound infection.In one patient this infection resulted in a mesh infection, which was treated conservatively.The other two patients were readmitted for diagnostic imaging of late abdominal complaints and ileus, which could not be explained by the surgical intervention.Considering the long-term follow-up, one patient (2.6%) had a mesh infection after 4 months requiring mesh explantation and implantation of a biological mesh.Considering the short-term follow-up (three months): the median follow-up was 15 weeks (inter quartile range; iqr: 7-19 months) in which the median number of outpatient clinic visits was 3 (iqr: 2-4).None (0%) of the 46 patients had a recurrence during this period.At the outpatient clinic 38 patients (82.6%) were without pain.Three patients (6.5%) had mild abdominal pain without use of analgesics; four patients (8.7%) used analgesics daily for moderate abdominal pain.One of the patients (2.2%) suffered from severe pain.Long term follow up (one year or more): thirty-nine patients (85%) were included for long term follow up, median follow up was 25 months (iqr: 19-35 months).Median number of doctors' visits concerning hernia complaints was 0 (iqr 0-2).In total two patients (5.1%) had a recurrence.One of these patients had a pseudobursa and recurrence after 17 months requiring reoperation.The other patient had a recurrence after 19 months requiring reoperation.Thirty patients (77%) reported no pain.Nine patients (23%) reported pain complaints with a mean visual analogue scale (vas) score of 1.7 (range: 1-3).

• Brand Name: UNKNOWN PROGRIP MESH PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12060649
• MDR Text Key: 258163119
• Report Number: 9615742-2021-01552
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROGRIP MESH PRODUCT
• Device Catalogue Number: UNKNOWN PROGRIP MESH PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR